New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

28 August 2018

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Xofigo is indicated for the treatment of prostate cancer when medical or surgical castration does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms but has not spread to other internal organs.

To patients

  • Doctors will receive information about the new recommendations for use of Xofigo by letter.
  • You should contact your doctor if you are treated with Xofigo and have questions about your treatment.

To doctors

  • Xofigo should only be used as monotherapy or in combination with a luteinising hormone releasing hormone (LHRH) analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
  • Before, during, and after potential treatment with Xofigo, patients should have their risk of bone fractures checked thoroughly. Doctors should moreover consider using preventive measures – such as bisphosphonates or denosumab – as a means to increase bone strength, before starting or resuming treatment with Xofigo.
  • Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy).
  • The product should not be used in patients with osteoblastic bone metastases.

In March 2018, the EMA recommended not to use Xofigo in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone due to the risk of increased bone fractures. See the announcement in Danish at


The background leading to the recommendation is a review of data from a study suggesting that patients receiving Xofigo could have an increased risk of dying earlier and having more bone fractures than patients receiving ineffective calcium tablets (placebo).
The EMA has requested the responsible pharmaceutical company to investigate the cause of the potential risk of earlier death and the increased risk of bone fractures indicated by the study.


Read more about the PRAC recommendations here.